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Personnel Hygiene in Pharmaceuticals Industry SOPs

Personnel Hygiene in Pharmaceuticals Industry SOPs is created to improve personnel hygiene of the employees that work in the Pharmaceuticals Industry.

1. PURPOSE

To improve and maintain the conditions of personnel hygiene of the employees according to regulatory authority requirements and international standards.

2. SCOPE

This SOP applies to all employees entering the manufacturing and warehouse areas of Pharmaceuticals.

Personnel Hygiene

3. RESPONSIBILITY

3.1 HR Manager is responsible for initial and ongoing health examination of the employees.

3.2 Administration staff monitors personnel hygiene standards of all employees entering in process area and ensures that overall working environment of the company shall be as per SOP.

3.3 Department head / Section in-charge ensures observance of personnel hygiene of all employees and working environment standards on regular basis and informing HR Manager.

3.4 Q.A officer monitors the observance of SOP by all employees.

4. MATERIAL & EQUIPMENT

4.1 Not applicable

5. PROCEDURE

5.1 HR is responsible to ensure that all personnel prior to and during employment, as appropriate, undergo health examinations including the personnel conducting visual inspections also undergo periodic eye examinations on annual basis. HR is also responsible to maintain the record of health examination record of the employees.

5.2 All personnel are trained in the practices of personal hygiene. A high level of personal hygiene is observed by all those concerned with manufacturing processes. In particular, personnel are instructed to wash their hands before entering production areas. Signs to this effect are posted and instructions observed.

5.3 All section heads ensure that any person having an apparent illness or open lesions that may adversely affect the quality of products is not allowed to handle starting materials, packaging materials, in-process materials or drug products until the condition is no longer judged to be a risk.

5.4 All employees are instructed and encouraged to report to their immediate supervisor any conditions (relating to plant, equipment or personnel) that they consider may adversely affect the products.

5.5 Direct contact is avoided between the operator’s hands and starting materials, primary packaging materials and intermediate or bulk product.

5.6 To ensure the protection of the product from contamination, personnel wear clean body coverings appropriate to the duties they perform, including appropriate hair covering. Used clothes, if reusable, are stored in separate closed containers until properly laundered and, if necessary, disinfected or sterilized.

5.7 Smoking, eating, drinking, chewing, and keeping plants, food, drink, smoking material, and personal medicines is not permitted in production, laboratory and storage areas, or in any other areas where they might adversely influence product quality.

5.8 Personal hygiene procedures including the use of protective clothing apply to all persons entering production areas, whether they are temporary or full-time employees or non-employees, e.g. contractors from outsite’s employees, new visitors, inspectors, and Senior managers.

5.9 All employees are checked at the main gate for proper hygienic conditions by the admin staff on a fortnightly basis and recorded on the personnel hygiene form.

5.10 Non-compliance is reported to the respective section head for immediate rectification. In case of further noncompliance, disciplinary action is taken by the administration.

5.11 Workers are also checked on random/general observation on a required basis.

5.12 This form is further checked by the section heads and verified by the QA officer

5.13 INSTRUCTIONS:

Following instructions are given to the personnel:
5.13.1 Keep your lockers clean.
5.13.2 Do not store eatables, it attracts insects.
5.13.3 Wear the cap in a manner to cover hair completely.
5.13.4 Keep the toilets clean.
5.13.5 Wash the hands after visiting toilet and before entry to the Production area.
5.13.6 Person himself is responsible for look out of the workplace.
5.13.7 Do not use damaged dresses, shoes or caps.
5.13.8 Do not sit or sleep on floor.
5.13.9 Do not go out in company uniform.
5.13.10 Do not wear jewelry.
5.13.11 Cut your nails regularly.
5.13.12 Do not use any other room other than canteen for taking food.
5.13.13 Do not spit in inside the unit.
5.13.14 Smoking, eating, drinking, chewing or keeping plants, food, drink and personal medicine are not permitted in Production, laboratory, storage and other areas where they might adversely influence the product quality.
5.13.15 Smoking is prohibited.

6. REPORTING

6.1 Health examination record.

6.2 Personnel hygiene form

7. REFERENCE DOCUMENT

7.1 SOP for recruitment of employees.

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